WallFlex™ Colonic

GUDID 08714729902584

Stent System with Anchor Lock Delivery System

BOSTON SCIENTIFIC CORPORATION

Bare-metal colonic stent

• Primary Device ID: 08714729902584
• NIH Device Record Key: dc75d875-6fd4-425c-a28d-0511d1170953
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WallFlex™ Colonic
• Version Model Number: M00555760
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729902584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200257

FDA Product Code

• MQR: Stent, colonic, metallic, expandable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-03
• Device Publish Date: 2020-05-26

On-Brand Devices [WallFlex™ Colonic]

• 08714729902607: Stent System with Anchor Lock Delivery System
• 08714729902591: Stent System with Anchor Lock Delivery System
• 08714729902584: Stent System with Anchor Lock Delivery System